BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACUSYST-JR

    K Number: K872086 · Decision Jun 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    14

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    Basic Information

    Device Name
    ACUSYST-JR
    K Number
    K872086
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Endotronics, Inc.
    Date Received
    June 1, 1987
    Decision Date
    June 15, 1987
    Product Code
    KJH
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KJH Apparatus, Perfusion

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KJH), ordered by most recent decision date.

    ACUSYST-P/3X

    FDA 510(k)
    FDA Class 1 ·Hematology

    ACUSYST-P (CELL CULTURE EQUIPMENT)

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all

    Other Clearances by Endotronics, Inc.

    K Number Device Name
    K875151 ACUSYST-P/3X
    K864334 ACUSYST-P (CELL CULTURE EQUIPMENT)